Sustaining Generic Medicines Markets in Europe

Sustaining generic medicines markets 96International non-proprietary name: a single name awarded by the World Health Organizationfor each active substance that is marketed as a medicine. This name identifies the activesubstance rather than the final product which can be sold under different brand names.Licensed medicine: medicine with the same active substance as the originator medicine thathas an official licensing, distribution or co-marketing agreement with the originator medicinecompany.Originator medicine: the first version of a medicine developed and patented by an originatorpharmaceutical company which receives exclusive rights to marketing the medicine in theEuropean Union for 15 years.Patent: a document granting a company exclusive rights to exploit a new medicine for a givenperiod of time. The patent prohibits others from selling this medicine without the permission of thecompany in the territory where the patent was issued.Pharmaceutical form: the physical form in which a medicine is taken by patients as determinedby its route of administration. Pharmaceutical forms include tablets, capsules, injectables andliquids.Reference-pricing system: a system that establishes a reimbursement level or reference pricefor a group of interchangeable medicines. If a medicine is priced above the reference price, thepatient pays the difference between the price of the medicine and the reference price.Equivalence between medicines can be defined at three levels: 1) by active substance, i.e.medicines with the same active substance; 2) by pharmacological class, i.e. medicines withchemically-related active substances that are pharmacologically equivalent; 3) by therapeuticclass, i.e. medicines that have a comparable therapeutic effect.